Abstract: A method for the self-assembled production of a topographically surface structured cellulose element. First, a mold is provided having on one side a first surface which is in a complementary manner topographically structured and which is permeable to oxygen. Next, a liquid growth medium containing cellulose producing bacteria is provided. Then, the mold is placed to form a interface such that the side of the mold with the first surface is in direct contact with the liquid growth medium, and an opposite side is facing air or a specifically provided oxygen containing gas surrounding. This allows bacteria to be produced and deposit cellulose on the first surface and developing on the interface a surface structured surface complementary thereto, until a cellulose layer with a thickness of the element of at least 0.3 mm is formed. Finally; the element is removed from the mold.

Abstract: A replacement heart valve has an expandable frame configured to engage a native valve annulus and a valve body mounted to the expandable frame. The valve body can have a plurality of valve leaflets configured to open to allow flow in a first direction and engage one another so as to close and prevent flow in a second direction, the second direction being opposite the first direction.

Abstract: To provide a valve cusp sizer which is small and easy to handle. The present invention relates to a valve cusp sizer 100 for determining the size of a valve cusp depending on the size of a cardiac valve. The valve cusp sizer 100 includes a front surface 10 formed in an arcuate surface form to be abutted against an organism, a back surface 20 positioned on an opposite surface side of the front surface 10, and a pinching portion 30 protruding from the back surface 20. By removing a grip member and a grip member attachment portion from a conventional valve cusp sizer in this manner, and by forming the pinching portion 30 to be held by a clamp, tweezers, or the like, it is possible to dramatically miniaturize the valve cusp sizer while maintaining necessary functions of the valve cusp sizer.

Abstract: A method of delivering a prosthetic mitral valve includes delivering a distal anchor from a delivery sheath such that the distal anchor self-expands inside a first heart chamber on a first side of the mitral valve annulus, pulling proximally on the distal anchor such that the distal anchor self-aligns within the mitral valve annulus and the distal anchor rests against tissue of the ventricular heart chamber, and delivering a proximal anchor from the delivery sheath to a second heart chamber on a second side of the mitral valve annulus such that the proximal anchor self-expands and moves towards the distal anchor to rest against tissue of the second heart chamber. The self-expansion of the proximal anchor captures tissue of the mitral valve annulus therebetween.

Abstract: A replacement heart valve implant may include a braided anchor member configured to actuate between a delivery configuration and a deployed configuration formed from a plurality of filaments, a circumferential seal member disposed about a distal portion of the anchor member and including a reinforcing band disposed at a distal end thereof, and a plurality of valve leaflets connected to the anchor member. The reinforcing band is secured to the anchor member adjacent a distal end of the anchor member by a plurality of lashings each attached to two individual filaments. The plurality of filaments defines a body section, a proximal crown section, and a distal crown section, wherein the proximal crown section includes a first plurality of end loops and a second plurality of end loops, wherein a proximalmost extent of the first plurality of end loops and the second plurality of end loops varies.

Abstract: A prosthetic heart valve for replacing a native valve includes a collapsible and expandable stent extending between a proximal end and a distal end. The stent includes an annulus section adjacent the proximal end and having a first diameter, a plurality of first struts forming cells, and a plurality of second struts connected to the annulus section and forming a plurality of deflecting cells expandable to define a second diameter larger than the first diameter. A valve assembly is disposed within the stent and a cuff is coupled to the stent and covers the plurality of deflecting cells.

Abstract: Systems and methods for approximating tissue segments, such as mitral valve leaflets, on a minimally invasive basis. The system includes first and second approximation devices each including a magnetic component and an attachment mechanism. Each device is connected to a target tissue segment by the corresponding attachment mechanism. Upon deployment at a target site, the tissue approximation devices are magnetically attracted to one another, approximating the tissue segments and maintaining the tissue segments in the approximated state.

Abstract: A stented valve including a generally tubular stent structure that has a longitudinal axis, first and second opposite ends, a plurality of commissure support structures spaced from the first and second ends and extending generally parallel to the longitudinal axis, at least one structural wire positioned between each two adjacent commissure support structures, and at least one wing portion extending from two adjacent commissure support structures and toward one of the first and second ends of the stent structure. The stented valve further includes a valve structure attached within the generally tubular stent structure to the commissure support structures.

Abstract: A prosthetic apparatus includes a main body having a lumen and configured for placement within a native annulus of a native valve complex. The main body is radially compressible to a radially compressed state for delivery into the heart and self-expandable from the compressed state to a radially expanded state. The apparatus also includes at least one arm coupled to and disposed outside of the main body. The arm being coupled to the main body such that when the main body is compressed to the compressed state, a leaflet-receiving space between the arm and an outer surface of the main body increases to receive a native valve leaflet therebetween, and when the main body expands to the expanded state in the absence of any radial inward forces on the main body or the arm, the space decreases to capture the leaflet between the outer surface of the main body and the arm.

Abstract: Heart valve prostheses are provided having a self-expanding frame that supports a valve body comprising a skirt and a plurality of coapting leaflets. The self-expanding frame includes an inflow section, a valve section, and an outflow section. The outflow section forms attachment loops in a collapsed configuration to attach the frame to a delivery system.

Abstract: A method of crimping an implantable prosthetic valve can include placing protective material over at least a portion of the implantable prosthetic valve. The protective material can be configured to occupy space between open cells of a frame of the implantable prosthetic valve to prevent damage to a leaflet structure of the implantable prosthetic valve. The method can also include crimping the implantable prosthetic valve with the protective material on the implantable prosthetic valve, and removing the protective material from between the frame and the leaflet structure of the implantable prosthetic valve.

Abstract: Described is a prosthetic valve, comprising: an expandable stent including an inner lumen and having a first and a second end; and a spring attached to the first end of the expandable stent; wherein the expandable stent and the spring can expand radially to a desired diametric configuration in order to anchor the prosthetic valve at an implantation position in a body lumen. Related systems and methods.

Abstract: In some embodiments, a valve prosthesis includes an inlet portion that is substantially s-shaped and configured to engage the floor of the outflow tract of the native heart atrium. In some embodiments, a valve prosthesis includes a chordae guiding element configured to reduce bending of the chordae to reduce stress on the chordae during the cardiac cycle. In some embodiments, a valve prosthesis includes a central portion having an hourglass shape configured to pinch a native annulus in order to provide axial fixation of the valve prosthesis within a valve site. In some embodiments, a valve prosthesis includes a frame having an outflow end that is flared to provide a gap between an outflow end of the frame and an outflow end of prosthetic leaflets when the prosthetic leaflets are fully opened.

Abstract: The present invention relates to apparatus for methods for endovascularly replacing a patient's heart valve. The apparatus includes an expandable anchor with leaflet engagement elements on the proximal end of the anchor and a replacement valve. The leaflet engagement elements can be used to prevent distal migration and insure proper positioning of the apparatus.

Abstract: Described embodiments are directed toward centrally-opening leaflet prosthetic valve devices having a leaflet frame and a mechanically coupled leaflet. The described leaflet frames have projections that are configured to couple with apertures located within the leaflet attachment region of a leaflet. Some embodiments are further directed toward pulmonary valved conduits incorporating such leaflet and leaflet frame constructs. Methods of making and using such prosthetic valve devices are also described amongst others.

Abstract: Methods and devices for increasing flow in the left atrial appendage (LAA) include a conduit directing blood flow from a pulmonary artery into the LAA and/or a conduit drawing blood from the LAA by a Bernoulli effect. In one embodiment, a method comprises implanting a conduit in a pulmonary vein, expanding an inlet portion such that the conduit becomes anchored within the vein and directs blood through an outlet portion of the conduit into or toward the left atrial appendage.

Abstract: Stent-valves (e.g., single-stent-valves and double-stent-valves), associated methods and systems for their delivery via minimally-invasive surgery, and guide-wire compatible closure devices for sealing access orifices are provided.

Abstract: A mitral valve replacement device is adapted to be deployed at a mitral valve position in a human heart. The device has an atrial flange defining an atrial end of the device, a ventricular portion defining a ventricular end of the device, the ventricular portion having a height ranging between 2 mm to 15 mm, and an annulus support that is positioned between the atrial flange and the ventricular portion. The annulus support includes a ring of anchors extending radially therefrom, with an annular clipping space defined between the atrial flange and the ring of anchors. A plurality of leaflet holders positioned at the atrial end of the atrial flange, and a plurality of valve leaflets secured to the leaflet holders, and positioned inside the atrial flange at a location above the native annulus.

Abstract: The subject invention is directed to devices and methods for producing devices for regulating blood flow in the venous system. In particular, the invention provides for artificial valves designed to regulate the flow of blood in human vessels, wherein such artificial valves include superior properties including fatigue resistance, biocompatibility, and ease of manufacture.

Abstract: Apparatus and methods are described including a prosthetic atrioventricular valve (10) for coupling to a native atrioventricular valve (12). The prosthetic valve includes a support frame (20) and a covering (22), which at least partially covers the support frame. The support frame and the covering are shaped so as to define a downstream skirt (24). A plurality of prosthetic leaflets (40) are coupled to at least one element selected from the group consisting of: the support frame and the covering. An elongated anchoring member (152) is positioned around the downstream skirt in a subvalvular space (150), such that the anchoring member presses native leaflets (30) of the native valve against the downstream skirt, thereby anchoring the prosthetic valve to the native valve. Other applications are also described.

Abstract: A prosthetic heart valve includes a plurality of leaflets and an expandable member including one or more braided wires with a first set of wire segments extended helically in a first direction and a second set of wire segments extended helically in a second direction such that each wire segment of the first set intersects a plurality of wire segments from the second set at a plurality of intersection points. The one or more braided wires can have crowns where the wire segments of the first set connect to wire segments of the second set. The heart valve can include a tubular seal secured to the plurality of leaflets and to the expandable member by a plurality of sutures. The sutures can include cross stitches formed around both a wire segment of the first set and a wire segment of the second set at one of the intersection points.

Abstract: Systems for mitral valve repair are disclosed where one or more mitral valve interventional devices may be advanced intravascularly into the heart of a patient and deployed upon or along the mitral valve to stabilize the valve leaflets. The interventional device may also facilitate the placement or anchoring of a prosthetic mitral valve implant. The interventional device may generally comprise a distal set of arms pivotably and/or rotating coupled to a proximal set of arms which are also pivotably and/or rotating coupled. The distal set of arms may be advanced past the catheter opening to a subannular position (e.g., below the mitral valve) and reconfigured from a low-profile delivery configuration to a deployed securement configuration. The proximal arm members may then be deployed such that the distal and proximal arm members may grip the leaflets between the two sets of arms to stabilize the leaflets.

Abstract: An implantable device for regulating blood flow through a blood vessel comprising an elongated support dimensioned and configured to be implanted in a blood vessel. The support includes a linking member linking axially spaced apart portions to one another. A valve membrane extends between the axially spaced apart support portions and includes first region folded over the first linking member and attached thereto and a second region adjacent the first region and unattached to the first linking member. The second region is movable between a first position to enable blood flow and a second position to inhibit blood flow.

Abstract: A prosthetic heart valve device (100) for percutaneous replacement of a native heart valve includes an expandable retainer (110) at least partially surrounding and coupled to an inner valve support (120). The device can further include a prosthetic valve (130) coupled to the valve support. The retainer forms a donut-shaped flange (190) having an arcuate outer surface (142) for engaging tissue and an inner lumen defining a passage for blood to flow through the valve support. The retainer can include a plurality of circumferentially positioned, resiliency deformable and flexible ribs (114) which are coupled at their downstream ends 116 to the valve support 120. The flexible ribs, in one embodiment, can have a general C-shape configuration with the tips (117) of the flexible ribs and an opening (119) of the C-shape configuration oriented toward a longitudinal axis (101) of the device.

Abstract: Apparatus and methods are described including a prosthetic valve support (40) configured to be placed at a patient's native atrioventricular valve annulus. The valve support defines an annular element (44) that defines an inner cross-sectional area thereof. An expandable prosthetic valve (80) is placed into the patient's ventricle, the prosthetic valve including an expandable frame (79) and prosthetic valve leaflets (82) coupled to the frame. When the frame is in a non-constrained state thereof, a cross-sectional area of the frame, along at least a given portion L of the frame's length, is greater than the cross-sectional area defined by the annular element. The prosthetic valve is couplable to the prosthetic valve support at any location along the portion, by the frame being expanded when the location along the portion is aligned with the annular element. Other applications are also described.

Abstract: An implant can include a support component, a cover component, and a valve component. The valve component can be operable to permit flow through the implant. The implant can be delivered on a catheter, with one of the ends of the implant being selectively expanded to permit temporary occlusion of a vessel while delivering a material through the valve component to a downstream target region. The other end of the implant can thereafter be released such that the implant occludes the vessel, or the implant can be removed from the vessel entirely.

Abstract: A personalized prosthetic valve for implantation at a native valve treatment site includes a self-expanding mesh and a plurality of valve leaflets coupled to the mesh. The mesh may be delivered to the native valve in a collapsed configuration, and in an expanded configuration the mesh engages the native valve. The mesh in the expanded configuration is also personalized to match the treatment site, such that the outer mesh surface substantially matches the treatment site shape and size. The self-expanding mesh forms a central lumen configured to allow blood or other body fluids to pass therethrough. In the open configuration, blood passes through the prosthetic valve, and in the closed configuration, the plurality of leaflets are closer together and blood is prevented from flowing upstream through the prosthetic valve.

Abstract: Methods and devices are disclosed for treating neurovascular venous outflow obstructions, with or without implantation of a prosthetic valve. The valve may be carried by a support, such as a stent, which may be self-expandable or balloon expandable. Both transvascular and direct surgical access is contemplated.

Abstract: A prosthetic heart valve includes a stent body with a generally tubular annulus section, which may include one or more circumferential rows of cells. One or more prosthetic valve elements mounted to the stent body operate to allow blood flow in an antegrade direction but to substantially block flow in a retrograde direction. A cuff is attached to the stent body and positioned on a luminal surface of the stent body. At least one sealing member is attached to the cuff. The sealing member may be patch with an open side facing in a first axial direction and a closed side facing in a second axial direction opposite to the first axial direction. Flow of blood in the second axial direction will tend to force blood into the sealing member and cause the sealing member to billow outwardly relative to the stent body.

Abstract: Methods for increasing the fracture resistance of a polymer stent's drug-polymer coating and scaffolding including applying a coating and crimping using techniques that increase the resistance to fracture in the coating layer and scaffolding and scaffolding.

Abstract: The invention relates to an implantable device for use in the human and/or animal body to replace an organ valve, comprising a main body having a first end and a second end, wherein the first end and the second each have an opening to provide a fluid connection through the main body between the first end and the second end; a first membrane element arranged inside or at one end of the main body, wherein the membrane element is formed in such a manner that it allows the fluid connection through the main body in a first flow direction and blocks the same in a second flow direction opposite the first flow direction; wherein the main body has a large ratio of length to transverse expansion along the longitudinal axis of the main body in a first operating state (primary form) and a smaller ratio of length to transverse expansion along the longitudinal axis of the main body in a second operating state (secondary form); and wherein the main body can be reversibly transferred from the secondary form to the primary fo

Abstract: The invention provides a multi-component (modular) percutaneous valve device that includes a valve module having valve leaflets and a valve frame. The valve frame includes one or more, for example two, ring members and a plurality of masts. Also provided is a valve frame having specially designed pivot points at the connection between masts and first and second ring members to assist folding the valve module and minimizing delivery diameter. The valve frame may also include wire guides to facilitate combining the valve module with a support module. The masts or a ring of the valve frame may also include locking members, such as shafts for closing the valve module and securing the valve module to the support module. The support module includes corresponding locking members, such as spears that align with the shafts on the valve module for assembly and locking the valve module to the support module.

Abstract: Disclosed is an implantable mitral valve having an adjustable support. The support comprises a plurality of pairs of adjacent struts joined at apexes and a plurality of anchors for tissue engagement. The implant is adjustable to a first, reduced diameter for transluminal navigation and delivery to the left atrium of a heart. The implant may then expand to a second, enlarged diameter for the step of embedding the anchors into tissue surrounding and/or including the mitral valve. The implant may then be adjusted to a third, intermediate diameter, pulling the tissue radially inwardly, thereby reducing the native mitral valve annulus and supporting the prosthetic mitral valve.

Abstract: In a surgical method for improving cardiac function, an implantable scaffold or valve support device is inserted inside a patient's heart and attached to the heart in a region about a natural mitral valve. The scaffold or valve support device defines an orifice and, after the attaching of the scaffold or valve support device to the heart, a prosthetic or bio-prosthetic valve is seated in the orifice. The scaffold or valve support device is at least indirectly secured to cordae tendenae of the heart.

Abstract: Excessive dilation of the annulus of a mitral valve may lead to regurgitation of blood during ventricular contraction. This regurgitation may lead to a reduction in cardiac output. Disclosed are systems and methods relating to an implant configured for reshaping a mitral valve. The implant comprises a plurality of struts with anchors for tissue engagement. The implant is compressible to a first, reduced diameter for transluminal navigation and delivery to the left atrium of a heart. The implant may then expand to a second, enlarged diameter to embed its anchors to the tissue surrounding and/or including the mitral valve. The implant may then contract to a third, intermediate diameter, pulling the tissue radially inwardly, thereby reducing the mitral valve and lessening any of the associated symptoms including mitral regurgitation.

Abstract: A vascular connector configured to bypass an occluded vessel comprises a primary graft stem and a venous outflow stem. In general, the primary graft stem accepts a blood flow from an occluded vessel to bypass the occlusion. The venous outflow stem may extend from a wall of the primary graft stem and divert a portion of the blood flow to a native vein or other vessel of the vascular system. This configuration is beneficial in ensuring adequate blood flow at the vascular connector to inhibit the formation of clots and to extend the patency of the vascular connector.

Abstract: A medical treatment system and method of treatment is described having an implant that can be positioned and deployed, then undeployed to allow repositioning of the implant. The system includes a self-expanding medical implant that longitudinally foreshortens upon radially expanding from a radially compacted state, a distal interface configured to attach the implant to a distal mount of a delivery device, and a proximal interface configured to attach the implant to a proximal mount of the delivery device. Moving the distal mount longitudinally away from the proximal mount applies a longitudinal tension to the implant causing the implant to expand longitudinally and contract radially, and moving the distal mount toward the proximal mount reduces a longitudinal tension in the implant allowing the implant to expand radially toward a fully expanded state.

Abstract: Artificial heart valve structures and methods of their fabrication are disclosed. The heart valve structures may be fabricated from a biocompatible polymer and include one or more heart valve leaflet structures incorporated within a conduit. The valve structures may incorporate one or more conduit sinuses, as well as a gap between the lower margin of the valve leaflets and the interior of the conduit. In addition, the valve structures may include one or more valve sinuses created in a space between the valve leaflets and the conduit inner surface. Computational fluid dynamics and mechanical modeling may be used to design the valve leaflets with optimal characteristics. A heart valve structure may also incorporate a biodegradable component to which cells may adhere The incorporated cells may arise from patient cells migrating to the biodegradable component, or the component may be pre-seeded with cells prior to implantation in a patient.

Abstract: A vascular implant for replacing a native heart valve comprises a self expanding stent supporting a valve body having leaflets. The stent preferably comprises an anchoring structure configured to prevent the implant from passing through the valve annulus. For delivery, the implant is compacted within a delivery device and secured at one end. During delivery the implant is partially released from the delivery device, and positioning of the implant can be verified prior to full release. The implant can be at least partially resheathed and repositioned if desired.

Abstract: Heart valve assembly systems and methods configured for medical interventional procedures. In one aspect, the methods and systems involve a modular approach to treatment.

Abstract: A vascular implant for replacing a native heart valve comprises a self expanding stent supporting a valve body having leaflets. The stent preferably comprises an anchoring structure configured to prevent the implant from passing through the valve annulus. For delivery, the implant is compacted within a delivery device and secured at one end. During delivery the implant is partially released from the delivery device, and positioning of the implant can be verified prior to full release. The implant can be at least partially resheathed and repositioned if desired.

Abstract: A prosthesis and a method of controlling flow through a bodily lumen are provided. The prosthesis includes a body having a proximal portion, a distal portion and a lumen extending therethrough. The prosthesis also includes a first valve and a second valve operably connected to the body. The first valve has a proximal portion, a distal portion, a distal end extending distally relative to the proximal portion of the body and a lumen extending through the first valve. The first valve is closed in the absence of a second and third pressure that are greater than a first pressure. The second valve has a proximal portion, a distal portion, a distal end extending distally relative to a proximal portion of the body and a lumen extending through the second valve, the distal end of the first valve extending distal to the distal end of the second valve.

Abstract: The invention relates to a biological or artificial valve prosthesis (4, 5) for use in the human or animal body for replacement of an organ valve or a vessel valve, in particular a cardiac valve prosthesis or venous valve prosthesis, with a stent (8) or without a stent, with a supporting valve framework, with at least one valve (7) and with at least one conductor loop (2) that forms the inductance of an electrical resonance circuit. In order to provide a simple and inexpensive valve prosthesis that can be viewed in the MR imaging technique and is also easy to implant, the invention proposes that the at least one conductor loop (2) forms the valve framework and/or the valve (7) or supporting areas of the valve framework and/or supporting areas of the valve (7).

Abstract: A cardiac valve repair device has a membrane assembly and a frame. The frame has a central structure that defines a central separation, a pair of sleeves positioned below the central structure, and a pair of atrial alignment expansion beams. Each atrial alignment expansion beam has a curved section and inner section at each opposite end that defines a scissor-crossing where they overlap each other to form a separate lower expansion clip beam at each of the opposite ends thereof. The cardiac valve repair device also includes a pair of upper expansion clip beams. A V-shaped ventricular expansion curved beam extends below the two sleeves, with the membrane assembly secured to the V-shaped ventricular expansion curved beam. A pair of ventricular alignment stabilizing beams extends downwardly from the two sleeves.

Abstract: An implantable prosthetic valve has an in situ formable support structure. The valve comprises a prosthetic valve, having a base and at least one flow occluder. A first flexible component is incapable of retaining the valve at a functional site in the arterial vasculature. The first component extends proximally of the base of the valve. A second flexible component is incapable of retaining the valve at a functional site in the arterial vasculature. The second component extends distally of the base of the valve. At least one rigidity component combines with at least one of the first and second flexible components to impart sufficient rigidity to the first or second components to retain the valve at the site.

Abstract: Implantable medical devices are described. For example, various implantable medical devices having a sleeve with differential wall thicknesses are described. An exemplary medical device comprises a frame and a sleeve that has a first configuration where the sleeve is in an extended position and a second configuration where the sleeve is in an inverted position.

Abstract: A prosthetic heart valve configured to replace a native heart valve and for post-implant expansion and having a valve-type indicator thereon visible from outside the body post-implant. The indicator communicates information about the valve, such as the size or orifice diameter of the valve, and/or that the valve has the capacity for post-implant expansion. The indicator can be an alphanumeric symbol or other symbol or combination of symbols that represent information about the characteristics of the valve such as the valve size. The capacity for post-implant expansion facilitates a valve-in-valve procedure, where the valve-type indicator conveys information to the surgeon about whether the implanted valve is suitable for the procedure and informs the choice of the secondary valve.

Abstract: A valve with a frame and valve leaflets that provide a sinus pocket. The valve provides for unidirectional flow of a liquid through the valve.

Abstract: A heart valve prosthesis configured for deployment within a native heart valve. The heart valve prosthesis includes a tubular stent and a prosthetic valve component disposed within and secured to the stent. In addition, at least two positioning elements are coupled to a distal end of the stent to position and anchor the prosthesis within the native heart valve. Each positioning element transforms from a compressed configuration in which the positioning elements distally extend from the distal end of the stent to a deployed configuration in which the positioning elements proximally extend from the distal end of the stent. Each positioning element includes at least one U-shaped or V-shaped support arm that bends radially outward and then towards an outer surface of the stent such that it translates more than ninety degrees from the compressed configuration. Each positioning element may include an outer support arm and an inner support arm.

Abstract: Disclosed is a prosthetic heart valve incorporating one or more linking elements adapted for anchoring, aligning, stabilizing, fixing, or otherwise enabling the implantation of other prosthetic devices, including other prosthetic heart valves, in or around the heart.